RecruitingNot ApplicableNCT05457595

Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies

Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies


Sponsor

CNAO National Center of Oncological Hadrontherapy

Enrollment

55 participants

Start Date

Feb 24, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized form of radiation therapy (called re-irradiation) for women whose gynecological cancer has come back in the pelvis or groin area after previous treatment. Researchers want to know if this radiation approach can help when surgery is not an option. **You may be eligible if...** - You are 18 or older - Your gynecological cancer has returned in the pelvic or groin region (confirmed by scan or biopsy) - You previously received radiation to the pelvis - Surgery is not considered a safe option for you - Your disease is otherwise stable (no new spread elsewhere for at least 6 months) **You may NOT be eligible if...** - Your cancer has actively spread to other areas of the body - There is not enough safe distance between your tumor and nearby intestines - You are unable to provide medical imaging files from your prior treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONcarbon ion radiation therapy

CIRT: Planning Target Volume (PTV) will be delivered a total dose of 48-52.8 GyRBE in 12 fractions, 4 fractions per week. Treatment duration 3 weeks. Treatment lasting more than 5 weeks or cases of treatment with less than 6 fractions in 14 consecutive days will not be accepted.


Locations(1)

CNAO

Pavia, Pv, Italy

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NCT05457595